Regulatory Operations Consulting

Efficiencies to Streamline your End-to-End Process

In the past year, nearly every regional authority has introduced updates to its eCTD validation criteria. Life science companies must quickly respond to these changes in global regulatory requirements, or risk errors. Factor in the lingering uncertainty following a flurry of consolidation in the vendor community, and the impending eCTD mandate from the FDA, and you can imagine why it’s critically important to have a partner with industry insight you can trust.

Our team of experts will work to streamline your existing submission process, and share eCTD best practices. First, we will work with you to identify any potential roadblocks that may impact the timing and/or quality of your eCTD submission. Based on our analysis and your feedback, we will propose resolutions and mitigations to those risks. We are also able to help generate submission-ready deliverables by engaging stakeholders upstream in the process. Our engaged support department and secure CLOUD-based software suite make remote collaboration easier than ever.